(102 days)
No
The summary describes a composite material for securing denture attachments and includes performance testing based on material properties, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device is a composite material used to secure denture attachments; it does not directly treat or prevent a disease or condition.
No
The device is a composite material used to secure denture cap attachments, which is a structural or restorative function, not a diagnostic one. It does not identify, detect, or monitor a disease, condition, or health status.
No
The device is a composite material, which is a physical substance, not software. The description details its chemical composition and physical properties, and the performance studies focus on material characteristics like flexural strength and water sorption.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to process attachments for dentures, either chairside or in a laboratory. This is a mechanical/material application, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states it's a composite material used to secure denture attachments. It doesn't mention analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on material properties like flexural strength, flexural modulus, water sorption, and water solubility. These are relevant to the physical performance of a dental material, not the accuracy of a diagnostic test.
- Lack of Diagnostic Metrics: There are no mentions of typical diagnostic metrics like sensitivity, specificity, AUC, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.
Product codes
EBI
Device Description
Chairside Attachment Processing Material is a composite that is used to secure denture cap attachments into dentures. These attachments are commonly used in conjunction with dental implants to assist in affixing dentures to the wearer. Chairside Attachment Processing Material can be used chairside (to pick up the attachments from the mouth of the patient) or in a laboratory setting (using a model of the patient's mouth).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Chairside or laboratory procedure.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included performance testing. Performance testing to demonstrate substantial equivalence included methods described in the standards ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers and ISO 4049 Dentistry - Polymer-based restorative materials. The following testing was performed:
- Flexural strength per ISO 20795-1
- Flexural modulus per ISO 20795-1
- Water Sorption per ISO 4049
- Water Solubility per ISO 4049
Clinical data were not submitted in this premarket notification.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Key Metrics
Not Found
Predicate Device(s)
K110440, K021586, K092912, K011211
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
JUN 1 6 2014
Chairside® Attachment Processing Material K140570
510(k) Summary
Zest Anchors, LLC
Chairside® Attachment Processing Material K140570
June 3, 2014
ADMINISTRATIVE INFORMATION
Manufacturer Name
Official Contact
Representative/Consultant
Zest Anchors, LLC 2061 Wineridge Place Escondido, CA 92029 +1 (760) 743-7744 ext. 140 Telephone: +1 (760) 743-7975 Fax:
Annie Wright Regulatory Affairs Manager
Kevin A. Thomas, Ph.D. Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 +1 (858) 792-1235 Telephone: +1 (858) 792-1236 Fax: kthomas@paxmed.com Email: flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name Common Name
Classification Name Classification Regulations Product Code
Classification Panel Reviewing Branch
Chairside® Attachment Processing Material Resin, denture, relining, repairing, rebasing
Denture relining, repairing, or rebasing resin Class II, 21 CFR 872.3760 EBI
Dental Products Panel Dental Devices Branch
1
INTENDED USE
Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.
DEVICE DESCRIPTION
Chairside Attachment Processing Material is a composite that is used to secure denture cap attachments into dentures. These attachments are commonly used in conjunction with dental implants to assist in affixing dentures to the wearer. Chairside Attachment Processing Material can be used chairside (to pick up the attachments from the mouth of the patient) or in a laboratory setting (using a model of the patient's mouth).
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent to the following predicate devices:
- . VOCO GmbH, Quick Up (K110440)
- IMTEC Corporation, SECURE (K021586) .
- Danville Materials, Inc., Starfill 2B HV, Starfill 2B LV (K092912) ●
- DMG USA, Inc., Flowable Composite (K011211) .
The subject device, Chairside Attachment Processing Material, has a similar formula to the device cleared in K092912. The subject device is both self-curing and UV-light curing similar to those cleared in K110440, K021586, and K092912. The application of the subject device is similar to those cleared in K110440, K021586, and K092912. The intended use of the subject device is similar to those cleared in K110440, K021586, and K011211.
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included performance testing. Performance testing to demonstrate substantial equivalence included methods described in the standards ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers and ISO 4049 Dentistry - Polymer-based restorative materials. The following testing was performed:
- Flexural strength per ISO 20795-1 :
- Flexural modulus per ISO 20795-1 .
- Water Sorption per ISO 4049 .
- Water Solubility per ISO 4049 .
Clinical data were not submitted in this premarket notification.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
2
Overall, Chairside Attachment Processing Material has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design, ●
- incorporates the same or very similar materials, and .
- has similar packaging. .
3
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 19903 New Hampshire Avenue Document Control Center - WO66-Ci60 Silver Spring, MD 20993-0002
June 16, 2014
Zest Anchors, LLC c/o Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K140570
Trade/Device Name: Chairside® Attachment Processing Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: April 10, 2014 Received: April 11, 2014
Dear Dr. Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Dr. Thomas
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
MaryStibner-s
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Chairside® Attachment Processing Material
510(k) Summary
Indications for Use
K140570 510(k) Number:
Chairside® Attachment Processing Material Device Name:
Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Sheena A. Green
2014.06.13 08:00:12-04:00